FDA Defines “Gluten-Free” for Food Labeling

By August of 2014, all FDA-regulated foods labeled “Gluten-Free” must contain less than 20 ppm of gluten or manufacturers face regulatory enforcement. The rule is long awaited good news for those with celiac disease.

There is an undeniable air of excitement at the national Celiac Disease Foundation (CDF) offices in Southern California. CDF leadership and staff fielded calls, emails and social media inquiries in the wake of the FDA’s gluten-free food labeling rule. Upon hearing news about the rule, media, constituents and the public instinctively turned to CDF for clarification.

On August 2, 2013, the FDA published a regulation defining the term gluten-free for voluntary food labeling. According to the rule, products labeled gluten-free must contain less than 20 ppm [parts per million] of gluten. The rule applies to all FDA-regulated foods including dietary supplements.

Manufacturers have until August 5, 2014, to bring package labels into compliance. After that, gluten-free labeled foods containing 20 ppm or more of gluten are deemed misbranded and manufacturers are subject to regulatory enforcement action.

“On behalf of those with celiac disease and non-celiac gluten sensitivity and their support networks, we applaud the FDA for ensuring that food products labeled gluten-free will be safe for consumption,” stated Marilyn Geller, Chief Executive Officer of Celiac Disease Foundation.

Ms. Geller continued by expressing her gratitude “to the celiac community, the CDF Medical Advisory Board and our colleagues from the American Celiac Disease Alliance, Celiac Sprue Association, Gluten Intolerance Group and National Foundation for Celiac Awareness, who joined with CDF in a determined and collaborative effort for a federal gluten-free labeling standard.”

CDF Founder, Elaine Monarch, one of the first to advocate for a federal gluten-free standard stated, “Congratulations to the FDA for acknowledging the dietary requirements of people with celiac disease with this important ruling. I am extremely pleased that the FDA has established a definition of gluten-free that will enable easier identification of appropriate foods for us.” Ms. Monarch explains, “There is no pill for us; a gluten-free diet is the only treatment for celiac disease. That makes food both our drug and potentially our poison.”

Even though manufacturers have until August 5th of next year to comply with the new rule, the FDA in encouraging the food industry to come into compliance as soon as possible.

Similarly, Joseph A. Murray, MD, Professor of Medicine, Mayo Clinic and CDF Medical Advisory Board Member declared, “This long awaited regulation defining what a label saying gluten-free means, goes a long way to help build consistency in food labeling which will make it easier for people who need to be gluten-free to select food items. Manufacturers now know exactly what gluten-free means and will hopefully begin using this voluntary labeling standard immediately to provide safe food with clear information for consumers.”

The public is encouraged to visit the CDF website at http://www.celiac.org if they have any questions regarding the FDA’s new rule.

About Celiac Disease Foundation: Celiac Disease Foundation (CDF) is a non-profit corporation founded in 1990 and dedicated to remaining at the forefront of providing services and support regarding celiac disease and dermatitis herpetiformis through its awareness, education, advocacy and research programs. CDF is a founding member of the American Celiac Disease Alliance (ACDA). To learn more about celiac disease or CDF visit http://www.celiac.org.

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Marilyn’s Message

Relatively Rare. Relatively Minor. Relatively Easy to Treat. For more than 50 years, the celiac community has been led to believe that the above statements about the disease were true. We – those of us who live with the disease or who took care of someone with the disease – knew, however, that managing celiac disease […]

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